AAMC reviewing conflict-of-interest policies for clinical research

Academic medical centers seek to tighten rules governing drug company sponsorship of research activities.

By Jay Greene, amednews staff. June 11, 2001.

In an effort to restore public trust in clinical research activities, a task force created by the Assn. of American Medical Colleges met last month to begin revising AAMC's 10-year-old conflict-of-interest guidelines for academic researchers.

During the past four years, at least two academic health centers and one research facility have been sued in part over failure to disclose the financial interest of faculty members.

All academic institutions have policies for monitoring potential conflicts. However, research published last year showed there is a wide range of ways in which medical schools and teaching hospitals manage conflicts, according to studies in the Nov. 1, 2000, issue of the Journal of the American Medical Association (http://jama.ama-assn.org/issues/v284n17/abs/joc01590.html) and the Nov. 30, 2000, issue of the New England Journal of Medicine (http://content.nejm.org/cgi/content/abstract/343/22/1616).

"Our meeting reinforced the view that the public and our own community view [conflict of interest] as an important issue that warrants improvement," said Jordan Cohen, MD, AAMC president. "Our guidelines are valid, but there is a desire among the group to be more specific to give institutions further guidance."

The 28-member task force -- which includes clinical investigators, patients and representatives from medical schools and teaching hospitals -- will review and update AAMC's 1990 guidelines on faculty conflicts of interest. In 2002, the task force will develop a new set of principles for addressing institutional financial conflicts of interest in clinical research.

"Task force members at some institutions that have broad disclosure policies say there is a great administrative burden for reviewing all possible conflict," said Jennifer Kulynych, PhD, the AAMC's director of the division of biomedical research and task force staff member.

A delicate balance

While the task force agreed that tighter policies are needed, care must be taken not to totally prohibit pharmaceutical companies from providing help in research activities.

"Total prohibition might drive clinical researchers out of academic centers and into the private sector, where there also are variations in conflict disclosures," Dr. Kulynych said.

Other questions the task force addressed is whether there should be an institutional policy of disclosing financial interest to research subjects or whether that should be left to individual institutional review boards, the bodies that govern research at facilities, Dr. Kulynych said.

The AAMC task force is expected to adopt several principles and guidelines developed last year by a group of eight of the top 10 National Institutes of Health-funded medical schools. The principles under consideration by the AAMC task force include:

Requiring disclosure of financial interests to the institutional review boards that approve clinical research trials. Only about 1% of institutions require such disclosure.
Applying required disclosure of financial ties to anyone involved in research, including faculty, students and staff. Disclosure should be both on a set periodic basis and in real time if their situation changes.
Asking institutions to consider a higher standard for clinical research than for basic laboratory research.
Defining financial interests that should be disclosed to include any fees, honoraria or gifts associated with consulting or lectures, equity (including stock options) and payments for directorships or executive roles.